Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fast-Cath Transseptal Guiding Introducer Recalled by St Jude Medical Inc Due to St. Jude Medical is recalling a single batch...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St Jude Medical Inc directly.
Affected Products
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Quantity: 26
Why Was This Recalled?
St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Where Was This Sold?
This product was distributed to 3 states: FL, KY, OK
About St Jude Medical Inc
St Jude Medical Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report